BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALIVARY STONE EXTRACTOR BASKET SSEB

    MDR report key: 6763893 · Received August 3, 2017

    Report

    Report Number
    1820334-2017-02162
    Event Type
    Malfunction
    Date Received
    August 3, 2017
    Date of Event
    July 10, 2017
    Report Date
    January 29, 2018
    Manufacturer
    COOK INC
    Product Code
    GCJ
    UDI-DI
    00827002237971
    PMA / PMN Number
    K120468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A DOCUMENT BASED INVESTIGATION HAS BEEN PERFORMED WHICH INCLUDED REVIEW OF DRAWINGS, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS ALSO CONDUCTED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE WAS RETURNED WITH THE HANDLE AND THE BASKET FORMATION IN THE OPEN POSITION. THE COLLET KNOB IS TIGHT AND SECURE. THE MALE LUER LOCK ADAPTER (MLLA) IS TIGHT. THE POLYETHYLENE TEREPHTHALATE TUBING (PETT) MEASURES 3 CM IN LENGTH. A FUNCTIONAL TEST NOTED THE HANDLE ACTUATES THE BASKET FORMATION TO THE FULLY OPEN POSITION. A VISUAL EXAMINATION NOTED THE BASKET FORMATION IS SMASHED. THE WIRES LOOK CROSS, ALL WIRES ARE PRESENT AND SECURE. SEVERAL KINKS NOTED IN BASKET SHEATH FROM HOW THE CUSTOMER RETURNED THE DEVICE PRESSED BETWEEN TWO TRAYS. THE CUSTOMER HAS STATED THAT ONE OF THE WIRES WERE BROKEN, HOWEVER DURING THE INVESTIGATION, ALL OF THE WIRES WERE FOUND TO BE INTACT. CURRENT CONTROLS ARE IN PLACE IN MANUFACTURING TO ASSURE DEVICE FUNCTIONALITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE TWO NON-CONFORMANCES NOTED. THE NON-CONFORMANCE IDENTIFIED AS ¿DAMAGED¿ COULD POSSIBLY BE RELATED TO THE REPORT FAILURE. THE OTHER NON-CONFORMANCE IS UNRELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY REVEALED ONE ADDITIONAL COMPLAINT FOR LOT NUMBER 8003322. THIS OTHER COMPLAINT WAS FOR THE REPORTED ISSUE OF FOREIGN MATTER FOUND DURING INCOMING INSPECTION. THE REPORTED COMPLAINT OF BROKEN WIRE WAS NOT CONFIRMED, BUT BASKET DAMAGE WAS CONFIRMED BASED ON THE RETURNED DEVICE. ALL DEVICES ARE INSPECTED FOR PROPER FUNCTIONING AND INTEGRITY BEFORE PACKAGING. IT IS MOST LIKELY THE BASKET BECAME DAMAGED DURING SHIPPING OR HANDLING OF THE DEVICE, BUT THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHILE PREPARING FOR A SIALOENDOSCOPY PROCEDURE THE SALIVARY STONE EXTRACTOR BASKET (SSEB) PACKAGE WAS OPENED. IT WAS OBSERVED THAT ONE OF THE WIRES WAS BROKEN; THEREFORE, THE DEVICE WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED BY OPENING A NEW BASKET. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545424 SALIVARY STONE EXTRACTOR BASKET SSEB GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COOK INC 00827002237971

    Patients

    Seq Age Sex Outcome Treatment
    1 SIALENDOSCOPE.